In a session entitled, “The Patient and Health Technology Assessment: Challenges and Opportunities,” health experts from Dublin, Ireland will discuss how the prevalence of the “Celtic Gene,” coupled with the patient voice, impacted the Ministry of Health decision on reimbursement of a drug to treat Cystic Fibrosis (CF). Dr. Edward McKone, MD, Senior Clinical Lecturer at the School of Medicine & Medical Science at St. Vincent’s Hospital will present evidence supporting the reimbursement for the new CF drug and Orla Tinsley, BA, Ambassador of The Women’s Fund in Dublin, Ireland will present the patient’s perspective on the drug. Dr. Michael Barry, MD, Clinical Director of the National Centre for Pharmacoeconomics at St. James’s Hospital will present the health technology assessment (HTA) of the CF drug, and finally, James Reilly, JD, the Minister for Health at the Department of Health for the Government of Ireland will explain the ultimate health decision. Speaker and Congress Co-Chair, Dr. Michael Barry says, “Using the new cystic fibrosis drug, ivacaftor, as a case study, the first plenary session offers a fascinating insight into the tension between patients demanding such therapy, an HTA agency making a negative recommendation, and the payer struggling to afford this expensive therapy.”

In addition, in the session, “Should Multi-Criteria Decision Analysis (MCDA) Replace Cost-Effectiveness Analysis (CEA) for Evaluation of Health Care Coverage Decisions,” Dr. Karl Claxton, PhD, Professor of Economics from the Centre for Health Economics at the University of York will defend his position that MCDA should not be used in health care coverage decisions against Dr. Rob Baltussen, PhD, Head of Research from Nijmegen International Center for Health Systems Research and Education (NICHE), who argues that MCDA should be used in health care coverage decisions. Dr. Andrew Thomson, PhD, Head of Epidemiology, VRMM, Medicines and Healthcare Products Regulatory Agency (MHRA) in London will provide the regulator’s perspective on these issues. Dr. J. Jaime Caro, MD, Senior Vice President of Research at Evidera and moderator of the session states, “MCDA holds promise of incorporating into decisions many factors citizens find important –severity, fairness, innovation, etc. I want the speakers to take a position on whether or not this is enough to replace CEA or will difficulties in weighting, across populations and decisions limit this to a technique mainly of academic interest.”

The efficiency of the process of getting good technologies to the patient will be discussed in the session, “Early Engagement Between Manufacturers, HTA Assessors, and Regulators: Learning from the Past to Guide the Future.” Attendees will hear the HTA Agency and EUnetHTA perspectives from Dr. Leeza Osipenko, PhD, Senior Scientific Advisor, Scientific Advice Programme at the National Institute for Health and Care Excellence (NICE) and Dr. Mira Pavlovic, MD, Deputy Director for Health Technology Assessment at Haute Autorité de Santé (HAS). In addition, Dr. Jens Gruger, PhD, Vice President, Global Pricing & Market Access at F. Hoffman – La Roche AG will provide the Industry perspective, while Dr. Sheila Killalea, MD, Member of the Scientific Advice Working Party, the European Medicines Agency, and Senior Clinical Assessor for the Irish Medicines Board will provide the Regulator’s perspective. Session moderator and Congress Co-Chair, John Hutton, BPhil, Professor of Health Economics from the Department of Health Sciences at the University of York says, “To achieve efficient adoption of new technologies, manufacturers must provide the information decision makers need. This session examines how early interaction between the two groups can facilitate the design of optimal data collection programmes to support drug development.”

With over 2,000 abstract submissions, the ISPOR 16th Annual European Congress is shaping up to have record-breaking attendance of health payers, decision makers, technology assessors, regulators and governing bodies from around the world.

To register for the ISPOR 16th Annual European Congress, please visit:

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ABOUT ISPOR

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (www.ispor.org) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health. Media Contact: Danielle Mroz, MA, Director, Communications, ISPOR (dmroz@ispor.org).